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Cidara Therapeutics, Inc. (CDTX) receives an $11.14 million milestone payment from Mundipharma following the European approval of REZZAYO™ for the treatment of invasive candidiasis. The approval was based on positive results from the ReSTORE Phase III clinical trial, demonstrating statistical non-inferiority to the standard of care. Cidara plans to advance its Cloudbreak platform for the development of targeted immunotherapies, with a focus on cancer patients.
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-3.16%
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Cidara Therapeutics, Inc. (Nasdaq: CDTX) announces that the United Kingdom (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) has approved REZZAYO (rezafungin acetate) for the treatment of invasive candidiasis in adults, expanding treatment options for patients globally. The approval follows positive results from the ReSTORE Phase III clinical trial, demonstrating statistical non-inferiority for weekly-dosed rezafungin compared to the standard of care. Cidara has partnered with Mundipharma, entitled to receive a $2.8 million milestone payment for the MHRA approval.
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-2.23%
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Cidara Therapeutics, Inc. (Nasdaq: CDTX) announced the approval of REZZAYO (rezafungin acetate) in the European Union (EU) for the treatment of invasive candidiasis in adults. The approval is based on the positive results from the pivotal ReSTORE Phase III clinical trial, supported by the STRIVE Phase II clinical trials and an extensive nonclinical development program. Cidara is entitled to receive a milestone payment of approximately $11.14 million from Mundipharma for the European Medicines Agency (EMA) approval.
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11.11%
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Cidara Therapeutics, Inc. (Nasdaq: CDTX) announced promising preclinical data on its novel, multi-specific CD73/PD-1 targeting drug-Fc conjugate (DFC) candidate at the ESMO Immuno-Oncology (IO) Annual Congress, showcasing significant tumor growth reduction and superior anti-tumor activity to monotherapies.
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-2.37%
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Cidara Therapeutics, Inc. (Nasdaq: CDTX) has completed enrollment in the Phase 3 ReSTORE trial in China evaluating the efficacy and safety of rezafungin as a treatment for candidemia and invasive candidiasis. The trial included 52 patients and is expected to provide top-line data in Q2 2024. Rezafungin has received FDA approval in the U.S. and a positive CHMP opinion in the EU, with a final decision expected soon. Melinta Therapeutics has exclusive commercialization rights to REZZAYOTM in the U.S., and Mundipharma has rights in all other geographies except the U.S. and Japan.
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-2.69%
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Melinta Therapeutics, LLC and Cidara Therapeutics, Inc. (NASDAQ: CDTX) have announced the publication of pooled data from two completed global clinical trials evaluating REZZAYO® (rezafungin for injection) for the treatment of candidemia and invasive candidiasis. The publication in The Lancet Infectious Diseases demonstrates the non-inferiority of REZZAYO as compared to caspofungin for all-cause mortality and provides additional evidence for potential early treatment benefits.
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2.09%
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Cidara Therapeutics, Inc. (Nasdaq: CDTX) will present new preclinical data on its dual-acting CD73/PD-1 targeting drug-Fc conjugate (DFC) candidate at the ESMO Immuno-Oncology (IO) Annual Congress. The company will also present new preclinical data on CBO421, its first-in-class CD73 targeting DFC. The conference is scheduled for December 6-8, 2023, virtually and in-person in Geneva, Switzerland.
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Cidara Therapeutics, Inc. (Nasdaq: CDTX) has been named a Top Workplace by The San Diego Union-Tribune, reflecting the company's commitment to fostering a supportive work environment. The recognition is based on employee feedback gathered through a third-party survey, measuring critical culture drivers. Cidara's president, Jeffrey Stein, expressed pride in the company's dedication to bringing novel therapies to patients.
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Cidara Therapeutics announces new preclinical data on its drug-Fc conjugate candidate, CBO421, which shows potential for inhibiting tumor growth in solid tumors. The CD73-targeting DFC combines small molecule inhibitors and monoclonal antibodies against CD73, demonstrating best-in-class activity to inhibit immune evasion by cancer cells. The company plans to advance this candidate into clinical trials for the treatment of solid tumors.
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-6.36%
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Cidara Therapeutics, Inc. reported financial results for Q3 2023, including revenue of $12.7 million and $46.3 million for the three and nine months ended September 30, 2023, respectively. The company received positive CHMP opinion for rezafungin, and Melinta received a product-specific J-Code and NTAP for REZZAYO. Janssen Pharmaceuticals delivered an Election to Proceed Notice for CD388, and Cidara received a $7.0 million milestone payment. Cash and cash equivalents totaled $48.7 million as of September 30, 2023.
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Cidara Therapeutics, Inc.
Nasdaq:CDTX
CDTX Rankings
CDTX Stock Data
51.37M
76.81M
7.53%
30.63%
0.22%
Biological Product (except Diagnostic) Manufacturing
Manufacturing
United States of America
SAN DIEGO
About CDTX
cidara is a biotechnology company focused on the discovery, development, and commercialization of novel anti-infectives for the treatment of diseases that are inadequately addressed by current standard of care therapies. our first product candidate is cd101 iv, a potential once-weekly intravenous therapy being developed for the treatment and prevention of systemic fungal infections. our second product candidate, cd101 topical, is a topical formulation of cd101, the first topical application of the enchinocandin class of anti-fungals, for the treatment of vulvovaginal candidiasis, or vvc. in addition, we have developed a proprietary immunotherapy technology platform, cloudbreak™, which we use to create compounds designed to direct a patient’s immune cells to attack and eliminate pathogens that cause infectious disease. we are developing our first cloudbreak development candidate, c001, for the treatment of invasive aspergillosis.